21 C.F.R. § 880.2900 Clinical color change thermometer.
Title 21 - Food and Drugs
(a) Identification. A clinical color change thermometer is a disposable device used to measure a patient's oral, rectal, or axillary (armpit) body temperature. The device records body temperature by use of heat sensitive chemicals which are sealed at the end of a plastic or metal strip. Body heat causes a stable color change in the heat sensitive chemicals. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in §880.9. [45 FR 69682–69737, Oct. 21, 1980, as amended at 61 FR 1123, Jan. 16, 1996; 66 FR 38804, July 25, 2001]
Title 21: Food and Drugs
PART 880—GENERAL HOSPITAL AND PERSONAL USE DEVICES
Subpart C—General Hospital and Personal Use Monitoring Devices
§ 880.2900 Clinical color change thermometer.
